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Last Updated: September 28, 2021

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Drug Master Files for: HALOPERIDOL DECANOATE


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HALOPERIDOL DECANOATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10946 A II 6/13/1994 JANSSEN PHARMACEUTICA NV HALOPERIDOL (R001625) DRUG SUBSTANCE
10954 A II 6/23/1994 JANSSEN PHARMACEUTICA NV HALOPERIDOL DECANOATE
12530 A II 5/28/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD HALOPERIDOL DECANOATE
14226 A II 6/22/1999 EXCELLA GMBH AND CO KG HALOPERIDOL
15279 I III 10/4/2000 PLASDENE GLASS PAK EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL
>DMF No. >Status >Type >Submission Date >Holder >Subject

Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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